POS0640 OLOKIZUMAB IMPROVED PATIENT REPORTED OUTCOMES IN MTX AND TNF INCOMPLETE RESPONDER RHEUMATOID ARTHRITIS PATIENTS: RESULTS FROM THE LONG TERM EXTENTION TRIAL
Authors: V. Strand, E. Feist, E. Nasonov, T. Lisitsyna, A. Lila, S. Kuzkina, M. Samsonov, R. M. Fleischmann
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Olokizumab (OKZ) is an interleukin-6-inhibitor for treatment of RA. We present patient reported outcomes (PROs) reported in a long-term extension trial (OLE) (ClinicalTrials number NCT03120949). <h3>Objectives</h3> To assess long-term effect of OKZ treatment in patient global assessment of disease activity (PtGA), pain, physical function (HAQ-DI), fatigue (FACIT-F) and health related quality of life (SF-36 physical (PCS) and mental (MCS) component summary and domain scores). <h3>Methods</h3> Patients (pts) who completed phase III core studies (within 24 weeks) were continued on OKZ 64 mg q2w or q4w, or were randomized 1:1 to receive OKZ 64 mg q2w or q4w following placebo (PL) or adalimumab (ADA) in RCTs with an OLE period of up to week 82. PROs through CORE and OLE phases are summarized as observed data by treatment groups using descriptive statistics. <h3>Results</h3> Baseline demographics and disease characteristics of 2104 enrolled pts were comparable between groups. The achieved improvement from CORE baseline to OLE baseline in PtGA, Pain, HAQ-DI, FACIT-F, SF-36 PCS, MCS and all domains under treatment with OKZ q2w and q4w was maintained over the full observation period of 106 weeks (Table 1, Figure 1). SF-36 improvements reported from OLE BL continued (in 5 domains) or increased (in 3 domains: PF, RE and RP) with OKZ until week 82. <h3>Abbreviations</h3> AGNorms, age- and gender-matched normative values; BL, baseline; BP, bodily pain; GH, general health; MH, mental health; OLE-open label extension; PF, physical functioning; q2w, every 2 week; q4w, every 4 week; RE, role emotional; RP, role physical; SF, social functioning; VT, vitality. <h3>Conclusion</h3> Treatment with OKZ resulted in sustained improvement of PROs in MTX and TNF-IR RA pts over a period of up to 106 weeks. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Vibeke Strand Consultant of: Abbvie, Alpine Immune Sciences, Alumis, Amgen, Aria, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celltrion, Endo, Equillium, Ermium, Genentech/Roche, Gilead, GSK, Horizon, Inmedix, Janssen, Kiniksa, Lilly, Merck, MiMedx, Novartis, Omeros, Pfizer, Regeneron, R-Pharm, Samsung, Sandoz, Sanofi, Scipher, Setpoint, Sorrento, Spherix, Tonix, Urica;, Eugen Feist Consultant of: Abbvie, Eli Lilly, Galapagos, Medac, Novartis, Sanofi, Sobi, R-Pharm, Grant/research support from: Eli Lilly, Novartis, Pfizer, Evgeny Nasonov Consultant of: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Tatiana Lisitsyna Consultant of: R-Pharm, Alexander Lila Consultant of: Abbvie, Amgen, Bayer, Biotechnos, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, RPharm, Roche, Sanofi, Stada, Viatris and UCB, Grant/research support from: Novartis, Pfizer, Sofia Kuzkina Employee of: R-Pharm, Sofia Kuzkina Employee of: R-Pharm, Mikhail Samsonov Employee of: R-Pharm, Roy M. Fleischmann Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galvani, GlaxoSmithKlein (GSK), Janssen, Pfizer, Gilead, UCB, Novartis, Arthrosi, AstraZeneca, Flexion, Genentech, Horizon, Selecta, Viela, Vorso, Vyne.